Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors (NCT07373561) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors
800 participantsStarted 2026-06-01
Plain-language summary
The study aims to estimate the prevalence of post-intensive care syndrome (PICS) 12 months after ICU admission among adult ICU survivors in Denmark and to describe how this prevalence is distributed across the physical, cognitive, and mental health domains. By conducting follow-up assessments at 3, 6, and 12 months post-discharge, the study further seeks to determine the prevalence of PICS at each time point, characterise its temporal trajectory, and explore patients' symptom burden over time.
Research question
* What is the prevalence of PICS and its specific components (physical, cognitive, and mental health domains) among ICU survivors 12 months after ICU admission?
* How do the components of PICS evolve during the follow-up period (trajectory)?
* What risk factors are associated with the development of PICS in ICU survivors?
* Are there differences in PICS prevalence based on demographic or clinical characteristics (e.g., age, comorbidities, ICU length of stay)?
The hypothesis is that the prevalence of post-intensive care syndrome (PICS) in a Danish cohort of adult ICU survivors at 12 months will be approximately one third, defined as impairment in at least one of the three PICS domains (physical, cognitive, or mental health), measured using validated instruments with pre-specified cut-offs.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients ≥ 18 years of age
* Admitted to the intensive care unit for ≥48 hours
* Acutely admitted to the intensive care unit
Exclusion Criteria:
* Patients with limited treatment
* Foreign patients
* Pregnant women
* Patient with impaired cognitive function (e.g. dementia, intellectual disability)
* Patient without Danish citizenship
* Patient with limited proficiency in the Danish language
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is tracking symptoms up to 12 months after ICU discharge — what symptoms related to Post-Intensive Care Syndrome should I be watching for in myself or my loved one right now, even before this trial begins recruiting?
2Since this trial is observational and focused on measuring PICS rather than testing a treatment, would participating in it affect my current care plan in any way, or would it run alongside whatever treatment I'm already receiving?
3The trial isn't recruiting yet — given my current situation, is there a similar study or a PICS follow-up program already available that my care team could connect me with in the meantime?
4Post-Intensive Care Syndrome can involve physical, cognitive, and mental health problems — based on my specific ICU experience, which of those areas do you think I'm most at risk for, and how would that shape whether joining a study like this makes sense for me?
5Since this study is based in Denmark, is it actually accessible to me, and if not, are there comparable longitudinal studies or structured follow-up programs in my area that track ICU survivors over time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.